510(k) · Cleared
ClearedPillar Palatal Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · LRK Device, Anti-Snoring
Cleared on Feb 10, 2012 as substantially equivalent to K011723 (Pi Medical, 2002) after a 344-day review. Its family tree reaches back 6 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 10, 2012
- Review
- 344 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K920213 (1992). 13 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 5 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 4 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- 3 generations backK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- 2 generations backK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
- 1 generation backK011723 Anti-Snoring Device or AsdPi Medical · 2002
- This deviceK110623 Pillar Palatal Implant SystemMedtronic Xomed, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK181107 Elevo® Kit Snoring Intervention DeviceZelegent, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK213475 Elevo Snoring Intervention SetZelegent, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −5 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −4 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| −3 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| −2 | K981677 | Repose Bone Screw System | Influence, Inc. | 1999 | 2 |
| −1 | K011723 | Anti-Snoring Device or Asd | Pi Medical | 2002 | — |
| 0 (this device) | K110623 | Pillar Palatal Implant System | Medtronic Xomed, Inc. | 2012 | — |
| +1 | K181107 | Elevo® Kit Snoring Intervention Device | Zelegent, Inc. | 2018 | — |
| +2 | K213475 | Elevo Snoring Intervention Set | Zelegent, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011723 | Anti-Snoring Device or AsdSummary page 1…LRK- Device, Anti-Snoring 21 CFR 872.5570, Class 1I Premarket Notification: K01 1723 G. Purpose of Submission: Updating the labeling to the currently cleared Pillar Palatal Implant System. H. Device Description… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181107 | Elevo® Kit Snoring Intervention Device | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K181107 (Zelegent, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K011723.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
The Pillar Palatal Implant System is intended for use in stiffening the soft palate tissue which may reduce the severity of snoring in some individuals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110623: Pillar Palatal Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110623
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026